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Lawyer’s Guide to the Veterinary Feed Directive (“VFD”)

Lawline.com

November 3, 2016

By Cari B. Rincker, Esq.

Who I Am• Grew up on a beef cattle

farm in Illinois– Advanced degrees in animal

science• Past-Chair of the ABA,

General Practice, Solo & Small Firm Division’s Agriculture Law Committee

• Client bases ranges from livestock producers & food entrepreneurs to mid-size agri-businesses

Overview

Background

• Definitions• Players• Regulatory Framework

(Second) Veterinary Feed Directive (“VFD”) Rule

Background

Definitions

Antibiotics Antimicrobials Feed Additives

Vaccines Hormones Growth Promotants

DefinitionsAntibiotic• Can inhibit the growth of bad bacteria that cause infections

and illness.• Antibiotics belong to a class of drugs called “antimicrobials.”

Antimicrobial• Any substance of natural, semisynthetic or synthetic origin

that kills or inhibits the growth of microorganisms but causes little or no damage to the host

• All antibiotics are antimicrobials, but not all antimicrobials are antibiotics

Definitions

• Antibiotics can be administered as a feed additive • Given to farm animals in feed to fulfill a specific need (e.g., vitamins,

minerals, fatty acids, and minerals)

Feed Additives

• Low-level antibiotics can be used as a growth promotant

Growth Promotant

• Ionophores can be a type of growth promotant • Lipid-soluble molecule that transports ions across a cell membrane

Ionophores

DefinitionsHormones

• Hormones are chemicals naturally produced in the body.

• In terms of livestock, these include natural estrogen, progesterone, testosterone, and their synthetic versions.

Vaccines

• Produces immunity to a disease

• Can be administered through needle injections, by mouth, or by aerosol

• Injection of a killed or weakened organism that produces immunity in the body against that organism

Biologics

• All viruses, serums, toxins, and analogous products of natural or synthetic origin (e.g., vaccines, live microorganisms) intended for use in the diagnosis, treatment, or prevention of diseases of animals

Compare to antibiotics. Consumers confuse these terms.

DefinitionsResistance

• Antibiotic resistance occurs when an antibiotic has lost its ability to effectively control or kill bacterial growth; in other words, the bacteria are "resistant" and continue to multiply in the presence of therapeutic levels of an antibiotic.

Residues

• Traces of antibiotics in feed, in some cases, as a result of administering antibiotics to livestock used for meat and dairy. There are maximum antibiotic limits allowed in food products (i.e., Maximum Residue Limits or “MRLs”).

Commonly confused terms

Withdrawal Periods• The animal’s body will eventually metabolize

the antibiotic and eliminate it from its system. However, there are withdrawal periods for the time in between when the livestock was treated with antibiotics and the time of harvest or processing.

• This “withdrawal period” reduces any concentration of the antibiotic that might still be present in the animal’s body (and thus in the milk, meat, or eggs).

• Withdrawal periods are set by the FDA and it is different for each drug and species.

The PlayersU.S. Department of Agriculture (“USDA”) regulates antibiotics in meat, poultry, and eggs via three sub-agencies.• Food Safety Inspection Service (“FSIS”) (Primarily)• Agriculture Marketing Service (“AMS”)• Animal and Plant Health Inspection Service (“APHIS”)

Food & Drug Administration is an agency of the Department of Health and Human Services (“HHS”).• FDA regulates food and drugs in livestock animals excluding meat, poultry, and eggs (regulated by

USDA). • Center for Veterinary Medicine (“CVM”) is a sub-agency which oversees the safety and

effectiveness of animal drugs and the approval process.

Centers for Disease Control and Prevention (“CDC”) is also under the HHS umbrella and safeguards health by monitoring antibiotic resistance.• National Antimicrobial Residence Monitoring System (“NARMS”) is a sub-agency of the CDC

composed of the FDA, CDC, USDA’s FSIS.

Role of USDAFSIS

Pursuant to the Federal Meat Inspection Act (“FMIA”), the Poultry Productions Inspection Act (“PPIA”) and the Egg Products Inspection Act (“EPIA”), FSIS is the USDA sub-agency that oversees food labeling and whether meat or poultry is misbranded.

Random Tests at USDA - Inspected Processing Facilities

Violators are published with FSIS website (“Residue Violation Information System”)

Penalties include jail time and fines

AMSSub-agency that certifies food as “organic” under the National Organic Program (“NOP”)

APHISManages the National Health Monitoring System (“NAHMS”)

Conducts national studies on health and health management of U.S. domestic livestock and poultry populations

National Organic Program• USDA-AMS regulates NOP

– There must not be any administration of antibiotics under any circumstances; therefore, this could be viewed “antibiotic free” label regulation.

– If the animal gets sick in an “organic” livestock operation and organic approved methods fail, the animal may receive antibiotics, but then cannot be labeled as “organic” anymore under the NOP. See 7 CFR § 205.238(c)(7).

USDA-Regulated Marketing Claims

• All USDA label marketing claims must be approved by FSIS to determine if they are truthful and not misleading.– USDA’s FSIS is responsible for labeling

meat and poultry, liquid eggs and cooked egg.

– Look for the “USDA Process Verified” for this claim because the shield means that this was verified.

USDA-Marketing Claim• “No Antibiotics Used” requires the producer to submit food

formulations, pharmaceutical invoices, or other appropriate documentation verifying that animals have received antibiotics by any means. – They also must provide how they care for and treat sick animals. – In order to use this marketing claim, the animals must have never been

treated with antibiotics.

• Variations include: – No Added Antibiotics– No Antibiotics Added– No Antibiotics Administered– Raised without antibiotics-for meat and poultry only

Role of FDA

Meat

• Withdrawal periods

• Dosage

Poultry

• Antibiotic labels

• Use of antibiotics on livestock

USDA regulates eggs, poultry and meat with antibiotics

FDA regulates most other issues

Role of CDC• National Antimicrobial Residence Monitoring System (“NARMS”) is a

sub-agency of the CDC.– Players: Composed of the FDA, CDC, USDA’s FSIS

– Purposes: Its primary purpose is to track antibiotic residence in the United States. The primary objectives of the NARMS program are to:

• Monitor trends in antimicrobial resistance among foodborne bacteria from humans, retail meats, and animals;

• Disseminate timely information on antimicrobial resistance to promote interventions that reduce resistance among foodborne bacteria;

• Conduct research to better understand the emergence, persistence, and spread of antimicrobial resistance; and

• Assist the FDA in making decisions related to the approval of safe and effective antimicrobial drugs for animals.

Approval of Antibiotics

FDA Must Approve Antibiotics • Federal Food, Drug, and Cosmetic Act

(“FFDCA” or “FDCA”) prohibits an animal drug to be sold into interstate commerce unless is has been approved by an Approved New Animal Drug Application (“NADA”).

• FDA does approve the use of antibiotics in livestock and must approve all antibiotics (for humans, animals, and livestock). See 21 CFR § 530.

• This requirement still exists with VFD.

Background

Prior to 1996, FDA had 2 options for distributing animal drugs:•Over-the-Counter (“OFC”) •Prescription (Rx)

Federal Food, Drug and Cosmetic Act (“FDCA”) didn’t require prescriptions for animal feeds.•Medicated feeds were OTC•Viewed as being impractical because feed mills would need to have a pharmacist onsite to dispense prescription drugs; thus feeds were OTC.

Background

Statutory History

• In 1996, Congress enacted the Animal Drug Availability Act (“ADAA”) to facilitate the approval and marketing of new animal drugs and medicated fees.• This law created a new regulatory category for

animal drugs used in animal feed – veterinary feed directive (“VFD”) drugs.

• First VFD Rule by Food & Drug Administration (“FDA”) was published in the Code of Federal Regulations in 2000.• The Second VFD Rule was published on June 3,

2015

Background

Under ADAA, VFD drugs are new animal drugs intended for use in or on animal feed, which are limited by an approved application, conditionally approved application or index listing to use under professional supervision of a licensed veterinarian. • VFD drug requires a VFD document by

licensed veterinarian who authorizes the use.

• Although a similar concept, VFD drugs are not prescription (Rx) drugs

Background

A VFD is a written statement issued by a licensed veterinarian in the court of a the veterinarian’s professional practice that orders the use of a VFD drug or combination VFD drug in an animal feed.• This authorizes the livestock producer to

obtain and use animal feed bearing or containing a VFD drug or combination VFD drug to treat the producer’s livestock in accordance with the approved, conditionally approved application or index.

BackgroundBefore the Second VFD Rule, there were few VFD Drugs• FDA received responses saying that the

VFD process was overly burdensome.• FDA also received public comment

about public health, use of antimicrobials/antibiotics in meat producing animals, and concern for antibiotic residence.

• New VFD “responded” to these concerns.

Background

The final rule on VFD is the third of three core documents that the FDA is

using on its judicious use policy for antibiotics.

Publication 1: Guidance for the Industry (GFI) #209 “The Judicious

Use of Medically Important Antimicrobial Drugs in Food

Producing Animals”

Publication 2: Guidance for the Industry GFI #213 “New Animal Drugs

and New Animal Drug Combination Products Administered in or on

Medicated Feed or Drinking Water of Food-Producing Animals:

Recommendations for Drug Sponsors for Voluntarily Aligning Product Use

Conditions with GFI #209”

Background

• Published around April 2012 • Described the overall policy direction. • This publication focused on 2 key

principles:• Limit use of medically important

antimicropial drugs in food-producing animals to those uses (1) considered necessary for assuring animal health and (2) that include veterinary oversight or consultation

Publication 1: Guidance for the

Industry (GFI) #209 “The

Judicious Use of Medically Important

Antimicrobial Drugs in Food

Producing Animals”

Background

• Published in December 2013• Outlined a detailed process and timeline for implementing the

measures identified in GFI #209. • This document discussed the transition of OTC antimicrobial

drugs to VFD marketing status. • This publication noted that December 2016 was the target for

drug sponsors to implement changes to use conditions of “medically important” antimicrobials in food and water to:• (1) voluntarily withdraw approved production uses such as

“increased rate of weight gain” or feed efficiency and • (2) after the label changes these production uses will no

longer be legal; however, therapeutic uses are to be retained for treatment, control and prevention indications.

Publication 2: Guidance for the Industry GFI #213 “New Animal

Drugs and New Animal Drug Combination

Products Administered in or on Medicated Feed

or Drinking Water of Food-Producing

Animals: Recommendations for

Drug Sponsors for Voluntarily Aligning

Product Use Conditions with GFI #209”

Background

• A key principle noted in this publication was to include a veterinarian in the decision-making process.

• It doesn’t require direct veterinarian involvement in the drug administration but it does require use to be authorized by a licensed veterinarian in the context of a Veterinarian Client Patient Relationship (“VCPR”). • This includes water soluable products to Rx

(“medicated drinking water”) and products used in or on feed to VFD (“medicated feed”)

Publication 2: Guidance for the Industry GFI #213 “New Animal

Drugs and New Animal Drug Combination

Products Administered in or on Medicated Feed

or Drinking Water of Food-Producing

Animals: Recommendations for

Drug Sponsors for Voluntarily Aligning

Product Use Conditions with GFI #209”

Background

VFD – final rule published in the Federal

Register on June 3, 2015

Builds off of GFI #213 (“Publication 2”)

Provides for a phased enforcement of the

implementation of the rule as OTC become

VFD

FDA focusing now on stakeholder education • Veterinarians• Livestock producers• Feed mill distributors

Background – Effective Date

First VFD Rule (December 8, 2000) was in effect until

October 1, 2015

Second VFD Rule (June 2, 2015)

went into effect after October 1,

2015

BackgroundWhat drugs are affected? (Look

for 2 things)

Those that are considered “medically

important” AND

Administered in feed or drinking water• i.e., injectables, boluses

and other dosage forms are not affected

(GFI # 213)

Background

So what are “medically important”

antimicrobials?

• GFI #213 (Publication #2) defined “medically important” to include all antimicrobial drugs/drug classes that are listed in Appendix A of FDA’s Guidance #152

• Put simply, it includes all antimicrobial drugs that are considered important by the FDA for therapeutic uses

Background:Affected Antimicrobials Administered via Feed

Antimicrobial Class Specific Drugs Approved for Use in Feed

Aminoglycosides Apramycin, Hypgromycin B, Neomyscin, Streptomyscin

Diaminophyrimidines Ormetoprim

Lincosamides Lincomycin

Macrolides Erythromycin, Oleandomycin, Tylosin

Penicillins Penicillin

Streptogramins Virginiamycin

Sulfas Sulfadimethoxine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline

Tetracycline Chlortetracycline, Oxytetracycline

See FDA “Medically Important Antimicrobials in Animal Agriculture” at 15

Background:Affected Antimicrobials Administered via Water

Antimicrobial Class Specific Drugs Approved for Use in Water

Aminoglycosides Apramycin, Gentamicin, Neomyscin, Spectinomycin, Streptomyscin

Diaminophyrimidines NONE

Lincosamides Lincomycin

Macrolides Erythromycin, Oleandomycin, Tylosin

Penicillins Penicillin

Streptogramins NONE

Sulfas Sulfachlorophyrazine, Sulfachlorpyridazine, Sulfadimethozine, Sulfamerazine, Sulfamethazine, Sulfaquinoxaline

Tetracycline Chlortetracycline, Oxytetracycline, Tetracycline


Background

What drugs aren’t affected?

• Antimicrobials that are already VFD• Avilamycin, florfenicol, tilmicosin• Rx Tylosin

• Antimicrobials that are not “medically important”• Ionophores (e.g., monensin, lasalocid)• Bacitracin (e.g., bacitracin zinc)• Bambermycins• Carbodox

• Non-antimicrobial drugs• Anthelmentics• Beta agonists• Coccidiostats


Background

Feed-use drugs are assigned to one of two categories• Category I – Drugs having the lowest potential for

residues• Category II- Drugs having the highest potential for

residues• VFD drugs are no longer automatically Category II

This category determines whether a facility needs to be licensed to handle the drug in the Type A form

Veterinary Feed Directive (VFD)

Stakeholder Requirements

Veterinarians

Livestock Producers

Feed Distributors

Drug Manufacturers

Veterinary RequirementsMust be in compliance with the state’s veterinarian-client-patient relationship (“VCPR”) requirements pursuant to § 530.3(i)

If state doesn’t require a VCPR then FDA now requires that the VFD be issued within context of Federally defined VCPR, which requires:• Engage with livestock producer and assume responsibility for making

medical judgment about the animal’s health.• Have sufficient knowledge of the animal by virtue of examination and/or

visit the facility where the animal is managed to initiate a preliminary diagnosis.

• Provide for any necessary follow-up evaluation or care.

21 § CFR 558.6(b)

Veterinary Requirements

The veterinarian must also provide a written

veterinary feed directive (“VFD”).

The VFD must be in compliance with the

conditions for approved use,

conditionally approved use or indexed use under the ADAA.

21 CFR 558.6(a)


Extra-labeling Use is not permitted • I.e., Use of feed containing a VFD

drug in a manner other than as directed on the label is not permitted.

21 C.F.R. 558.6(a)


VFD Information

Required information

Optional information


• Vet’s and livestock producer/client’s • Name• Address• Telephone number

• Premises at which the animals are located

• Date of VFD issuance• Species and production class of animals

to be fed the VFD feed

Required Informatio

n


VFD must include the name of the VFD drug • could be the generic name• can state that a substitution drug

is or isn’t allowed (optional info) • if substitution is allowed then the

feed distributor may choose to substitute if the generic VFD is part of an approved combination

21 CFR 558.6(b)


VFD must include an expiration date• The vet can write a date up to 6

months from the date the VFD is initiated.

• Duration determines the length of time the VFD is allowed to be fed to the animals as specified on the product label.

• If no expiration date then 6 mo. is the default

Veterinary RequirementsVFD Must Include

• Approximate/potential number of animals to be fed by the expiration date of the VFD on a premises• Also needs the expiration date

• Indication for which the VFD is issued • Drug level• Duration of use

• Note: Duration is different than expiration date• Withdrawal time• Special instructions/cautions• Number of reorders (refills) authorized – if permitted by the drug

approval

Veterinary RequirementsNote that expiration date and the duration of use are 2 different concepts

Few examples:

• Avilamycin has an expiration date of 90 days but should only be used for 21 days

• Florfenicol for swine has an expiration date of 90 days but has a typical duration of only 5 days

• Tilmicosin for cattle has an expiration date of 45 days but typically prescribed for 14 days


VFD Must Include

this Statement

• “Use of feed containing this veterinary feed directive (VFD) drug in a manner other than as directed on the labeling (extralabel) is not permitted.”


VFD must include:• An affirmation of

intent for combination VFD drugs

• Veterinarian’s electronic or written signature

Veterinary RequirementsAffirming Intent on the VFD

Choice 1: “This VFD only authorizes the use of the VFD drug(s) cited in this order and is not intended to authorize the use of such drugs in combination with any other animal drugs.”

Choice 2: “This VFD authorizes the use of the VFD drug(s) cited in this order in the following FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.” [List specifics ______________________ ______________________________________________________]

Choice 3: “This VFD authorizes the use of the VFD drug(s) cited in this order in any FDA-approved, conditionally approved, or indexed combination(s) in medicated feed that contains the VFD drug(s) as a component.”


VFD must include premises ID but may include more information of the animals • This is so someone can locate the animals,

if needed.• May include specific information, such as

the pen or description of where the animals are currently located.

• If the VFD is intended to authorize the use of a VFD feed in a group of animals that are located at more than one physical location, then the VFD can specify more than one pen so long as the feed is supplied by a single feed distributor.

Veterinarian Requirements

VFD may provide the following additional information:

• Approximate age/weight range of the animals

• Any other information the veterinarian deems appropriate to identify the animals specified in the VFD


Please note that the VFD no longer requires the veterinarian to state the amount of feed to be fed to the animals

• Instead, the burden is on the distributor to determine the proper amount of feed to manufacture and distribute to the producer


Importantly, is not a required VFD Form• Guidance for the Industry

(“GFI”) #233 lists several recommended common formats for the VFD

• Veterinarian can create his/her own VFD form but should have it reviewed by an attorney for compliance

Veterinarian RequirementsCopy of the VFD must go to the client (producer) and feed distributor• Can be delivered hard-copy, facsimile or

electronic (e.g., email)• Transmitted to the distributor and client

gets copy

Must maintain VFD records for 2 years

• Must retain original VFD • Other segments can keep copies but the

veterinarian must keep original

21 C.F.R. 558.6(a)

Producer Requirements

Feed animal feed containing a VFD drug only to animals based upon a duly issued VFD from a licensed veterinarian

Maintain all VFD records for 2 years

• Keep copy in original form (hard copy v. original)

• Must be available for inspection and copying by FDA upon request

21 CFR 558.6(a)


Prohibited from feeding a VFD after an expiration date• The expiration defines the period

of time for which the authorization to provide an animal feed containing a VFD drug is lawful.

• Expiration date specifies the last day the VFD feed can be fed to a group of animals.


Veterinary Feed Directive Issuance

VFD should

state the expiration

date

Feed DeliveryMedicated feed being delivered

in different

increments

FeedingExpiration

Date

21 CFR 558.6(a)

Note: Was the duration prescribed different than the expiration date?

Who is a Feed “Distributor”?

Any person who distributes a medicated feed containing

a VFD drug to either:

• Another distributor or• Client-recipient of VFD

(livestock producer).

Feed Distributor Requirements

Shall only provide a VFD feed if the VFD contains all the required information and conforms to product approval

Maintain records for 2 years

• Keep copy in original form (hard copy v. original).• Must be available for inspection and copying by

FDA upon request.• Note that manufacturing records only need to be

kept for 1 year under 21 CFR Part 225 if distributor also manufacturers.

21 CFR 558.6(c)


Provide one-time notifications• To the FDA of the distribution of VFD

feeds stating that it intends to handle/distribute VFD drug-containing medicated feeds

• Acknowledgment of distribution limitations for VFD fees that the purchasers will sell the VFD feeds only to producers with valid VFD orders or to other distributors for whom they have acknowledgement notices


Notification must include:

• Distributor’s name and business address• Distributor’s signature (or agent’s signature)• Date the notification was signed

Must notify FDA within 30 days of any change in ownership or business info• Must send notification to FDA, Center of Veterinary

Medicine, Division of Animal Feeds


If the distributor is distributing the VFD feed to another distributor,

then an acknowledgement letter must be sent from the receiving

distributor under 21 CFR 558.3(b)(11) before shipment of feed.

Consigner distributor must

retain copy of acknowledgement letter for 2 years.

Drug ManufacturersAll labeling and advertising for (combination) VFD

drugs, feeds containing (combination) VFD drugs must have the following cautionary statement:

“Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order

of a licensed veterinarian.”

21 CFR 558.6(a)

Drug ManufacturersSubstitution of Drugs• If the VFD doesn’t specify that a generic

version may be substituted then the then the manufacturer may use an approved generic VFD drug to manufacture the VFD feed

• However, the manufacturer may not substitute a generic VFD drug for a pioneer VFD drug in a combination VFD feed if the generic VFD drug is not part of an approved combination VFD drug

FDA Enforcement

General surveillance and for-

cause inspection assignment

s

Timeline

This second VFD rule became effective on

October 1, 2015

December 2016 is the target for drug

sponsors to implement changes to

use conditions of products

January 1, 2017 target for switching OTC

drugs to VFD

Questions on Being an Agriculture Lawyer

• Fridays with Cari Skype Calls– First Friday of the

month at 2pm ET– RSVP to

[email protected]– No charge

mailto:[email protected]

Oh, P.S. – I Wrote a Book

Cari B. Rincker & Patrick B. Dillon, “Field Manual: Legal Guide for New York Farmers & Food Entrepreneurs” (2013)

Available at http://www.amazon.com/Field-Manual-Legal-Farmers-Entrepreneurs/dp/1484965191 , Kindle + iBooks

http://www.amazon.com/Field-Manual-Legal-Farmers-Entrepreneurs/dp/1484965191




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